Roche Holding AG (RHHBY.PK), Monday announced that the U.S. Food and Drug Administration has cleared its Elecsys pTau181 test, a blood-based Alzheimer's test indicated as an aid in the initial assessment for Alzheimer's and other causes of cognitive decline in the primary-care setting.
The minimally invasive test, developed in partnership with Eli Lilly and Company (LLY), would help clinicians with information to help patients in early stages of cognitive decline.
The test was evaluated in a multicenter, non-interventional clinical study, showing that it could rule out Alzheimer's pathology with a 97.9 percent negative predictive value.
Moving forward, Roche is advancing a comprehensive portfolio that has the potential to further shape diagnostic pathways and support earlier, more accurate detection of neurological diseases.
Currently, RHHBY is trading at $45.08, down 1.29 percent on the OTC Markets.
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